Effect of Virtual Reality on Patient Outcomes and Satisfaction in Total Knee Replacement

Not Applicable

Not yet recruiting

• Conditions: Knee Replacement; Knee Replacement Surgery; Postoperative Pain, Acute; Anxiety, Preoperative; Pain Management; Virtual Reality

• Registration Number: NCT06933732
• Lead Sponsor: Aykut Turgut

Brief Summary

This study aims to evaluate the effectiveness of virtual reality (VR) in managing preoperative anxiety and postoperative pain in patients undergoing total knee replacement. Investigators will assess the impact of preoperative VR training on anxiety levels, explore the effectiveness of relaxing and distracting VR videos for pain management after surgery, and determine the optimal timing for VR application by comparing different VR intervention times. Our goal is to identify how VR can improve both the emotional and physical recovery process for patients undergoing knee replacement surgery.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-02
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-16
• Last Update Submitted: 2025-04-16
• Study First Posted: 2025-04-18
• Last Update Posted: 2025-04-18
• Study Start: 2025-04-21
• Primary Completion: 2025-07-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Patients with an ASA score of 1, 2, or 3
• Elective unilateral total knee replacement surgery was planned,
• Patients who are able to read and write in Turkish

Exclusion Criteria

• Using >30 mg of oral oxycodone or equivalent daily
• Long-term opioid use (>12 weeks)
• Substance use disorder
• Scheduled for emergency surgery
• Scheduled for revision surgery
• Requiring postoperative intensive care
• Patients with visual or hearing impairments
• Individuals experiencing motion-related nausea or dizziness
• History of stroke or dementia
• Pregnant or breastfeeding women
• Patients with a history of epilepsy or seizures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Postoperative Pain Intensity as Measured by Visual Analogue Scale (VAS) at 2, 4, and 6 Hours After Surgery in Patients Receiving Virtual Reality Interventions.	Baseline (before VR intervention) and assessments at 2, 4, and 6 hours after surgery, with a 15-Minute wait after VR video completion before each pain assessment	0 = No pain 10 = Worst pain possible

Secondary Outcome Measures

Name	Time	Method
Preoperative Anxiety Measured Using the State-Trait Anxiety Inventory-State (STAI-S) Scale	Baseline (just before the educational video) and post-video (immediately after the educational video, Day 1)	Preoperative anxiety will be measured using the State-Trait Anxiety Inventory-State (STAI-S) scale, which is a validated tool for assessing temporary feelings of anxiety. Patients will complete the scale before undergoing any intervention or VR exposure. This measurement will provide an understanding of the patient's baseline anxiety level before the application of VR. This measurement will be taken twice: once before the patients view the educational videos and once after viewing them.; Total scores range from 20 to 80. Higher scores = Higher levels of anxiety.
Change from Baseline in Virtual Reality Sickness as Measured by the Virtual Reality Sickness Questionnaire (VRSQ)	Baseline (just before the educational video) and post-video (immediately after the educational video, Day 1)	The Virtual Reality Sickness Questionnaire (VRSQ) assesses the level of discomfort or sickness experienced by participants during or immediately after wearing the Virtual Reality headset.; Total scores range from 0 to 15, with higher scores indicating higher levels of discomfort or sickness.
Change in Body Temperature (Celsius) from Baseline	Baseline (just before VR intervention) and 2, 4, or 6 hours post-surgery, depending on the assigned group.
Patient Satisfaction as Measured by a 0-10 Numeric Rating Scale Post-Intervention	Postoperative, Day 1	Patient satisfaction will be measured using a 0-10 Numeric Rating Scale (NRS), where 0 represents no satisfaction and 10 represents the highest level of satisfaction.
Change in Heart Rate/min from Baseline	Baseline (just before VR intervention) and 2, 4, or 6 hours post-surgery, depending on the assigned group.
Change in Blood Pressure from Baseline (Systolic/Diastolic mmHg)	Baseline (just before VR intervention) and 2, 4, or 6 hours post-surgery, depending on the assigned group.
Change in Respiratory Rate/min from Baseline	Baseline (just before VR intervention) and 2, 4, or 6 hours post-surgery, depending on the assigned group.
Change in Blood Oxygen Saturation(%) from Baseline	Baseline (just before VR intervention) and 2, 4, or 6 hours post-surgery, depending on the assigned group.

Trial Locations

Locations (1)

Aibu Izzet Baysal Training and Research Hospital; 🇹🇷 Bolu, Turkey